Corticosteroids (systemic)

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INDICATIONS: - Intranasal:
Children >/= 6 years of age and Adults: Management of symptoms of
seasonal or perennial rhinitis. Nebulization:
Children 12 months to 8 years: Maintenance and prophylactic treatment of
asthma. Oral capsule: Treatment of active Crohn's
disease (mild to moderate) involving the ileum and/or ascending colon .
Oral inhalation: Maintenance and prophylactic treatment
of asthma; includes patients who require corticosteroids and those who
may benefit from systemic dose reduction/elimination.

CLINICAL PHARMACOLOGY
Budesonide has a high topical glucocorticosteroid (GCS) activity and a
substantial first pass elimination. The formulation contains granules
which are coated to protect dissolution in gastric juice, but which
dissolve at pH >5.5, ie, normally when the granules reach the duodenum.
Thereafter, a matrix of ethylcellulose with budesonide controls the
release of the drug into the intestinal lumen in a time-dependent
manner.

CONTRAINDICATIONS
ENTOCORT EC is contraindicated in patients with known hypersensitivity
to budesonide.

WARNINGS
Glucocorticosteroids can reduce the response of the
hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where
patients are subject to surgery or other stress situations,
supplementation with a systemic glucocorticosteroid is recommended.
Since ENTOCORT EC is a glucocorticosteroid, general warnings concerning
glucocorticoids should be followed.

Care is needed in patients who are transferred from glucocorticosteroid
treatment with high systemic effects to corticosteroids with lower
systemic availability, since symptoms attributed to withdrawal of
steroid therapy, including those of acute adrenal suppression or benign
intracranial hypertension, may develop. Adrenocortical function
monitoring may be required in these patients and the dose of systemic
steroid should be reduced cautiously.

Patients who are on drugs that suppress the immune system are more
susceptible to infection than healthy individuals. Chicken pox and
measles, for example, can have a more serious or even fatal course in
susceptible patients or patients on immunosuppressant doses of
glucocorticosteroids. In patients who have not had these diseases,
particular care should be taken to avoid exposure. How the dose, route
and duration of glucocorticosteroid administration affect the risk of
developing a disseminated infection is not known. The contribution of
the underlying disease and/or prior glucocorticosteroid treatment to the
risk is also not known. If exposed, therapy with varicella zoster immune
globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as
appropriate, may be indicated. If exposed to measles, prophylaxis with
pooled intramuscular immunoglobulin (IG) may be indicated. (See the
respective package insert for complete VZIG and IG prescribing
information.) If chicken pox develops, treatment with antiviral agents
may be considered

Dosing:Nasal inhalation: (Rhinocort® Aqua®): Children >/= 6
years and Adults: 64 mcg/day as a single 32 mcg spray in each nostril.
Some patients who do not achieve adequate control may benefit from
increased dosage. A reduced dosage may be effective after initial
control is achieved.
Maximum dose: Children <12 years: 128 mcg/day; Adults: 256 mcg/day

Oral: Adults: Crohn's disease: 9 mg once daily in the
morning; safety and efficacy have not been established for therapy
duration >8 weeks; recurring episodes may be treated with a repeat
8-week course of treatment

Note: Treatment may be tapered to 6 mg once daily for 2 weeks prior to
complete cessation. Patients receiving CYP3A4 inhibitors should be
monitored closely for signs and symptoms of hypercorticism; dosage
reduction may be required.

ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining properties, are used as replacement
therapy in adrenocortical deficiency states. Their synthetic analogs are
primarily used for their potent anti-inflammatory effects in disorders
of many organ systems.

CONTRAINDICATIONS
Systemic fungal infections and known hypersensitivity to components

Dosing:
If possible, administer glucocorticoids before 9 AM to minimize
adrenocortical suppression; dosing depends upon the condition being
treated and the response of the patient; Note: Supplemental doses may be
warranted during times of stress in the course of withdrawing therapy
Children:
Anti-inflammatory or immunosuppressive: Oral: 2.5-10 mg/kg/day or 20-300
mg/m2 /day in divided doses every 6-8 hours
Physiologic replacement: Oral: 0.5-0.75 mg/kg/day or 20-25 mg/m2 /day in
divided doses every 8 hours

Spinal cord compression: 10 to 100mg (Usually 10mg) IV
stat, followed by 4 to 24 mg IV every 6 hours. Use larger doses (eg up
to 100mg) in patients with profound neurologic injury and lower doses in
patients with mild or equivocal signs.

INDICATIONS: Florinef Acetate is indicated
as partial replacement therapy for primary and secondary adrenocortical
insufficiency in Addison's disease and for the treatment of salt-losing
adrenogenital syndrome.

Dosing (Adults): Addison's Disease: In Addison's disease,
the combination of Florinef Acetate (Fludrocortisone Acetate Tablets
USP) with a glucocorticoid such as hydrocortisone or cortisone provides
substitution therapy approximating normal adrenal activity with minimal
risks of unwanted effects. The usual dose is 0.1 mg of
Florinef Acetate daily, although dosage ranging from 0.1 mg three times
a week to 0.2 mg daily has been employed. In the event transient
hypertension develops as a consequence of therapy, the dose should be
reduced to 0.05 mg daily. Florinef Acetate is preferably administered in
conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or
hydrocortisone (10 mg to 30 mg daily in divided doses).

ACTIONS
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining properties, are used as replacement
therapy in adrenocortical deficiency states. Their synthetic analogs are
primarily used for their potent anti-inflammatory effects in disorders
of many organ systems.

CONTRAINDICATIONS
Systemic fungal infections and known hypersensitivity to components

INDICATIONS AND USAGE
CORTEF Tablets are indicated in the following conditions.

1. Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the first choice; synthetic analogs may be used in
conjunction with mineralocorticoids where applicable; in infancy
mineralocorticoid supplementation is of particular importance)
Congenital adrenal hyperplasia
Non suppurative thyroiditis
Hypercalcemia associated with cancer

2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient
over an acute episode or exacerbation) in:

Congenital adrenal hyperplasia: Oral: Initial: 10
to 20 mg/m2 /day in 3
divided doses; a variety of dosing schedules have been used. Note:
Inconsistencies have occurred with liquid formulations; tablets may
provide more reliable levels. Doses must be individualized by monitoring
growth, bone age, and hormonal levels. Mineralocorticoid and sodium
supplementation may be required based upon electrolyte regulation and
plasma renin activity.

Dermatosis: Children >2 years and Adults: Topical: Apply to affected
area 2-4 times/day (Buteprate: Apply once or twice daily). Therapy
should be discontinued when control is achieved; if no improvement is
seen, reassessment of diagnosis may be necessary.

Administration
Oral: Administer with food or milk to decrease GI upset.
Parenteral: Hydrocortisone sodium succinate may be administered by I.M.
or I.V. routes.
I.V. bolus: Dilute to 50 mg/mL and administer over 30 seconds to several
minutes (depending on the dose) .
I.V. intermittent infusion: Dilute to 1 mg/mL and administer over 20-30
minutes.
Topical: Apply a thin film to clean, dry skin and rub in gently.

CLINICAL PHARMACOLOGY
Methylprednisolone is a potent anti-inflammatory steroid with greater
anti-inflammatory potency than prednisolone and even less tendency than
prednisolone to induce sodium and water retention.

Methylprednisolone sodium succinate has the same metabolic and
anti-inflammatory actions as methylprednisolone. When given parenterally
and in equimolar quantities, the two compounds are equivalent in
biologic activity. The relative potency of A-Methapred sterile powder
and hydrocortisone sodium succinate, as indicated by depression of
eosinophil count, following intravenous administration, is at least four
to one. This is in good agreement with the relative oral potency of
methylprednisolone and hydrocortisone.

DOSING:
Dosing should be based on the lesser of ideal body weight or actual body
weight Only sodium succinate may be given I.V.;
methylprednisolone sodium succinate is highly soluble and has a rapid
effect by I.M. and I.V. routes. Methylprednisolone acetate has a low
solubility and has a sustained I.M. effect.

Adults: Only sodium succinate
may be given I.V.; methylprednisolone sodium succinate is highly soluble
and has a rapid effect by I.M. and I.V. routes. Methylprednisolone
acetate has a low solubility and has a sustained I.M. effect.

Asthma (Guidelines for the Diagnosis and Management
of Asthma - NHLBI, NIH., October 2007):
ADULTS:Long-term: For long-term treatment of severe
persistent asthma, administer single dose in a.m. either daily
or on alternate days (alternate-day therapy may produce less
adrenal suppression). 7.5 to 60 mg daily in a single dose in
a.m. or qod as needed for control.

Short-course 'burst': to achieve control, 40 to
60 mg per day as single or 2 divided doses for 3-10 days.

ASTHMA EXACERBATIONS
40 to 80 mg/day in 1 or 2 divided doses until PEF reaches 70
percent of predicted or personal best For outpatient 'burst,'
use 40 to 60 mg in single or 2 divided doses for total of 5 to
10 days in adults.

Anti-inflammatory or immunosuppressive: Oral: 2-60 mg/day in 1-4 divided doses to start,
followed by gradual reduction in dosage to the lowest possible level
consistent with maintaining an adequate clinical response.

I.V. (sodium succinate): 10 to 40 mg over a period of several minutes and
repeated I.V. or I.M. at intervals depending on clinical response; when
high dosages are needed, give 30 mg/kg over a period >/= 30 minutes and
may be repeated every 4 to 6 hours for 48 hours.

Status asthmaticus: I.V. (sodium succinate): Loading
dose: 2 mg/kg/dose, then 0.5-1 mg/kg/dose every 6 hours for up to 5 days

Aplastic anemia: I.V. (sodium succinate): 1 mg/kg/day
or 40 mg/day (whichever dose is higher), for 4 days. After 4 days,
change to oral and continue until day 10 or until symptoms of serum
sickness resolve, then rapidly reduce over approximately 2 weeks.

--------------------------------------------------AdministrationOral: Administer after meals or with food or milk

Parenteral: Methylprednisolone sodium succinate may be
administered I.M. or I.V.; I.V. administration may be IVP over one to
several minutes or IVPB or continuous I.V. infusion. Acetate salt should
not be given I.V.

DOSING:Oral: Dose depends upon condition being treated and
response of patient; dosage for infants and children should be based on
severity of the disease and response of the patient rather than on
strict adherence to dosage indicated by age, weight, or body surface
area. Consider alternate day therapy for long-term therapy.
Discontinuation of long-term therapy requires gradual withdrawal by
tapering the dose. Children: Anti-inflammatory or immunosuppressive dose: 0.05 - 2 mg/kg/day divided
1-4 times/day

Asthma long-term therapy (alternative dosing by age):
<1 year: 10 mg every other day
1-4 years: 20 mg every other day
5-13 years: 30 mg every other day
>13 years: 40 mg every other day

Asthma (Guidelines for the Diagnosis and Management
of Asthma - NHLBI, NIH., October 2007):
ADULTS:Long-term: For long-term treatment of severe
persistent asthma, administer single dose in a.m. either daily
or on alternate days (alternate-day therapy may produce less
adrenal suppression). 7.5 to 60 mg daily in a single dose in
a.m. or qod as needed for control.

Short-course 'burst': to achieve control, 40 to
60 mg per day as single or 2 divided doses for 3-10 days.

ASTHMA EXACERBATIONS
40 to 80 mg/day in 1 or 2 divided doses until PEF reaches 70
percent of predicted or personal best For outpatient 'burst,'
use 40 to 60 mg in single or 2 divided doses for total of 5 to
10 days in adults.

PACKAGE INSERT DATA
The initial dosage of DELTASONE Tablets may vary from 5 mg to 60 mg of
prednisone per day depending on the specific disease entity being
treated. In situations of less severity lower doses will generally
suffice while in selected patients higher initial doses may be required.
The initial dosage should be maintained or adjusted until a satisfactory
response is noted. If after a reasonable period of time there is a lack
of satisfactory clinical response, DELTASONE should be discontinued and
the patient transferred to other appropriate therapy. IT SHOULD BE
EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE
INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE
RESPONSE OF THE PATIENT. After a favorable response is noted, the proper
maintenance dosage should be determined by decreasing the initial drug
dosage in small decrements at appropriate time intervals until the
lowest dosage which will maintain an adequate clinical response is
reached. It should be kept in mind that constant monitoring is needed in
regard to drug dosage. Included in the situations which may make dosage
adjustments necessary are changes in clinical status secondary to
remissions or exacerbations in the disease process, the patient's
individual drug responsiveness, and the effect of patient exposure to
stressful situations not directly related to the disease entity under
treatment; in this latter situation it may be necessary to increase the
dosage of DELTASONE for a period of time consistent with the patient's
condition. If after long-term therapy the drug is to be stopped, it is
recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis: In the treatment of acute
exacerbations of multiple sclerosis daily doses of 200 mg of
prednisolone for a week followed by 80 mg every other day for 1 month
have been shown to be effective. (Dosage range is the same for
prednisone and prednisolone.)

ADT® (Alternate Day Therapy): ADT is a
corticosteroid dosing regimen in which twice the usual daily dose of
corticoid is administered every other morning. The purpose of this mode
of therapy is to provide the patient requiring long-term pharmacologic
dose treatment with the beneficial effects of corticoids while
minimizing certain undesirable effects, including pituitary-adrenal
suppression, the Cushingoid state, corticoid withdrawal symptoms, and
growth suppression in children.

The rationale for this treatment schedule is based on two major
premises: (a) the anti-inflammatory or therapeutic effect of corticoids
persists longer than their physical presence and metabolic effects and
(b) administration of the corticosteroid every other morning allows for
re-establishment of more nearly normal hypothalamic-pituitary-adrenal
(HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding
this rationale. Acting primarily through the hypothalamus a fall in free
cortisol stimulates the pituitary gland to produce increasing amounts of
corticotropin (ACTH) while a rise in free cortisol inhibits ACTH
secretion.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE
DISCLAIMER CAREFULLY BEFORE
ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE
TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
GlobalRPH does not directly or indirectly practice medicine or provide
medical services and therefore assumes no liability whatsoever of any
kind for the information and data accessed through the Service or for
any diagnosis or treatment made in reliance thereon.